Latest news with #VX-993
Yahoo
4 days ago
- Business
- Yahoo
7 Reasons Why Vertex Pharmaceuticals Is a No-Brainer Stock to Buy on the Dip
Key Points Vertex Pharmaceuticals stock sold off on two pipeline disappointments. The biotech company continues to grow with promising new drugs on the horizon. Vertex's price looks quite attractive, relative to its growth prospects. 10 stocks we like better than Vertex Pharmaceuticals › Vertex Pharmaceuticals (NASDAQ: VRTX) reported its second-quarter results after the market closed on Monday. Its shares plunged more than 17% in early trading on Tuesday. Were Vertex's Q2 results horrible? Not at all. Instead, investors reacted negatively after the big biotech company announced two disappointing developments with its pipeline. Such steep sell-offs can sometimes present great buying opportunities. I think that's the case with Vertex. Here are seven reasons why Vertex is a no-brainer stock to buy on the dip. 1. The bad news wasn't as horrible as the sell-off indicated One of Vertex's pipeline disappointments was that VX-993 didn't meet the primary endpoint in a phase 2 study evaluating the NaV1.8 pain signal inhibitor in treating acute pain following bunionectomy surgery. The other bad news was that the U.S. Food and Drug Administration (FDA) doesn't see a path for Vertex to obtain a broad label in peripheral neuropathic pain (PNP) for suzetrigine at this point. Vertex won't move forward with VX-993 as monotherapy in treating acute pain now. However, it's not the end of the world for a phase 2 program to flop. The company already markets Journavx (suzetregine) in treating acute pain. Also, Vertex isn't giving up on getting a broad PNP label for suzetrigine. It's regrouping, though, and prioritizing diabetic peripheral neuropathy (DPN) as its first PNP indication. The company plans to quickly initiate a second DPN phase 3 study. But Vertex will also work with the FDA to expand the DPN indication to add other neuropathic pain conditions and hopefully find a way to win a broad PNP label. 2. Journavx appears to be on track to become a megablockbuster Meanwhile, Journavx's commercial launch is humming along. Vertex CEO Reshma Kewalramani said in the Q2 earnings call that "formulary coverage is going really well," and "frankly, faster than I would have expected." She mentioned that the company's phase 4 confirmatory study data looks "really good, not only in terms of pain control, but also in terms of reducing opioid use." Chief Commercial Officer Duncan McKechnie revealed that Vertex is cranking up its marketing for Journavx and adding field support in response to the strong contracting and formula progress that has been achieved. He said the company is "receiving incredibly positive feedback from physicians and patients on how well Journavx is working for them clinically." According to McKechnie, Vertex remains highly confident that the pain drug will be another multibillion-dollar franchise for the company. 3. Vertex continues to grow robustly Almost lost in the shadow of the pipeline disappointments was the fact that Vertex continues to grow robustly. The company's revenue jumped 12% year over year in Q2 to $2.96 billion. It posted adjusted profits of $1.2 billion, a huge improvement from the $3.3 billion loss in the prior-year period (which was due to the Alpine acquisition). 4. Vertex's CF dominance is more secure than ever Vertex's dominance in cystic fibrosis (CF) appears to be more secure than ever. New CF drug Alyftrek is gaining momentum in the marketplace, especially with patients who haven't begun treatment with CFTR modulators or previously discontinued use of one of Vertex's other CF therapies. Alyftrek isn't just Vertex's best CF therapy yet. It should also be the company's most profitable CF drug because of a lower royalty burden, and its patents run through 2039. In addition, Vertex plans to restart the phase 1 dosing of VX-522 after a temporary pause. This messenger RNA therapy holds the potential to treat the 5,000 or so CF patients who can't benefit from Vertex's existing drugs. 5. Two new drugs could be on the way soon Vertex could soon add two new drugs with huge potential to its lineup. The company expects to file for regulatory approvals of zimislecel in treating severe type 1 diabetes in 2026. If all goes well with an interim analysis of a phase 3 study evaluating povetacicept in treating IgA nephropathy, Vertex could also file for accelerated approval of the drug in the first half of next year. 6. Trump administration policies aren't a problem for the company Some drugmakers could be hit hard by the Trump administration's tariffs on pharmaceutical imports and its plans to implement most-favored-nation (MFN) drug pricing. But not Vertex. CFO Charlie Wagner said in the Q2 call, "We expect an immaterial cost impact from tariffs in 2025 based on what we know today due to our significant U.S. presence and our geographically diverse supply chain." As for MFN, Kewalramani confirmed that Vertex didn't receive a letter that President Trump sent to multiple drugmakers demanding that they offer their medications to Medicare, Medicaid, and private insurers in the U.S. at the same low prices they charge outside the U.S. 7. The price is right Finally, the price is right to buy Vertex on the dip. The stock's price-to-earnings-to-growth (PEG) ratio, which is based on five-year earnings growth projections of analysts surveyed by LSEG, is a super-low 0.58. I don't think Vertex's pipeline disappointments will change the fact that this biotech stock remains attractively valued with its growth prospects factored into the equation. Do the experts think Vertex Pharmaceuticals is a buy right now? The Motley Fool's expert analyst team, drawing on years of investing experience and deep analysis of thousands of stocks, leverages our proprietary Moneyball AI investing database to uncover top opportunities. They've just revealed their to buy now — did Vertex Pharmaceuticals make the list? When our Stock Advisor analyst team has a stock recommendation, it can pay to listen. After all, Stock Advisor's total average return is up 1,039% vs. just 181% for the S&P — that is beating the market by 858.19%!* Imagine if you were a Stock Advisor member when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $631,505!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $1,103,313!* The 10 stocks that made the cut could produce monster returns in the coming years. Don't miss out on the latest top 10 list, available when you join Stock Advisor. See the 10 stocks » *Stock Advisor returns as of August 4, 2025 Keith Speights has positions in Vertex Pharmaceuticals. The Motley Fool has positions in and recommends Vertex Pharmaceuticals. The Motley Fool has a disclosure policy. 7 Reasons Why Vertex Pharmaceuticals Is a No-Brainer Stock to Buy on the Dip was originally published by The Motley Fool Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
5 days ago
- Business
- Yahoo
Vertex Pharmaceuticals (VRTX) Hits New All-Time Low on Failed Clinical Trial
We recently published . Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) is one of the worst-performing stocks on Tuesday. Vertex Pharmaceuticals nosedived on Tuesday to hit a new all-time low following the termination of a clinical trial for an experimental pain medicine. The company dropped as low as 21 percent to $373.2 before a slight uptick to close the day just down by 20.6 percent at $374.98 apiece. In a statement, Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) said that its clinical trial for VX-993 for the Treatment of Acute Pain 'did not result in a statistically significant improvement' to the enrolled patients. 'Based on these results, Vertex will not progress VX-993 into pivotal development as monotherapy in acute pain,' it said. The termination overshadowed the company's impressive earnings performance in the second quarter and first half of the year. During the quarter, Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) swung to a net income of $1.03 billion from a $3.593 billion net loss in the same period last year. Total revenues grew by 12 percent to $2.96 billion from $2.64 billion year-on-year. In the first half, Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) swung to a net profit of $1.68 billion from a $2.49 billion net loss year-on-year, while total revenues grew by 8 percent to $5.73 billion from $5.3 billion. While we acknowledge the potential of VRTX as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the .
Mint
6 days ago
- Business
- Mint
Vertex Falls After FDA Doubts Broad Use of Chronic Pain Drug
(Bloomberg) -- Vertex Pharmaceuticals Inc. fell after an experimental pain drug failed to benefit patients after surgery and US regulators said they didn't see a path forward for broad use of its pill in treating a chronic pain condition. Vertex has been trying to diversify beyond its core business of cystic fibrosis treatments. A key part of that strategy has been its new non-opioid pain drug, Journavx, which got US regulatory clearance in January. It was the first new type of painkiller to reach the US market in more than two decades. Shares of Vertex Pharmaceuticals fell as much as 14% in premarket trading on Tuesday. The stock is up 17% since the start of the year through Monday's close. The company is also developing the pill, a safer alternative to addictive opioids, for chronic pain caused by nerve damage. US Food and Drug Administration staff members reviewing a study of the drug said they didn't see a path forward for widespread use in the condition at this time, Vertex said in a statement disclosing its second-quarter earnings results. The drugmaker also has been studying other drugs in its pipeline to see if they have better efficacy than Journavx. The experimental pain drug VX-993 failed in a mid-stage study for treating acute pain, and Vertex halted its development as a standalone therapy for the condition, it said in a separate statement. The setback at the FDA and mid-stage trial failure 'should cause a rethink of the overall opportunity and risk profile for the pain franchise,' RBC Capital Markets analyst Brian Abrahams said in a note. The drugmaker said it would conduct a second trial of Journavx in patients with diabetic peripheral neuropathy, and won't start a final study that was being planned in a different condition. Diabetic peripheral neuropathy is 20% of the neuropathic pain market, Abrahams said. More than 110,000 prescriptions for the medicine have been written and filled for acute pain conditions since it became available in early March, the company said. The novel pain drug VX-993 didn't yield a statistically significant benefit for patients getting bunionectomy surgery, the company said. The failure suggests 'it may be more challenging than some expected to iterate and improve upon' Journavx, Abrahams said in a note. The FDA's stance removes the potential for Vertex to capture the broadest chronic pain market, he said. The company also reported second-quarter revenue and profit that came in ahead of analyst estimates, and reaffirmed its full-year revenue view. Chief Scientific Officer David Altshuler announced his plan to retire on Aug. 1, 2026. Mark Bunnage, the current senior vice president of global research, will take over the role on Feb. 1 as part of a transition plan, the company announced. --With assistance from Subrat Patnaik. (Updates with premarket shares in the third paragraph.) More stories like this are available on
Boston Globe
7 days ago
- Business
- Boston Globe
Vertex next-generation pain candidate fails Phase 2 trial
'We do not plan to advance VX-993 as monotherapy in acute pain, because we do not expect that it will be superior to our [existing] NaV1.8 inhibitors,' said CEO Reshma Kewalramani during a Monday afternoon earnings call with investors, using a scientific shorthand for the class of drugs. She noted that the company will continue a trial testing the drug in patients with diabetes who have chronic nerve pain. It was one of multiple setbacks the company disclosed for its pain franchise Monday, as it announced its second-quarter earnings. Advertisement Vertex also announced that longtime chief scientist David Altshuler was retiring next year, to be replaced by head of global research Mark Bunnage. Altshuler, an accomplished academic geneticist, took the post in 2015 and presided over the launch of its most important Advertisement Although Journavx was On Monday, though, the company disclosed that the the Food and Drug Administration 'indicated they do not see a path' for Vertex to obtain a broad approval for Journavx in 'peripheral neuropathic pain' — i.e., chronic pain caused by nerve damage or dysfunction. Instead the company will have to obtain approval in individual subsets of chronic pain. Accordingly, Vertex said it will cancel a planned Phase 3 trial in lumbosacral radiculopathy, also known as sciatica, which the company said affects about 4 million people. Journavx had already failed to outperform placebo in a Phase 2 sciatica trial. Instead it will launch a second Phase 3 trial in diabetic peripheral neuropathy, which affects about 2 million people, in the hope of first getting approval in that indication. At the same time, Vertex announced better-than-expected sales for Journavx in acute pain, with more than 110,000 prescriptions filled. Although the pill was hailed as a potential public health breakthrough for providing a non-addictive alternative to opioids, analysts questioned how widely they would be prescribed, given the availability of cheap alternatives. On Monday, Vertex said it earned $12 million from Journavx, compared to consensus Wall Street projections of $6.7 million. Advertisement Vertex also said it has now treated 29 patients with Casgevy, its gene editing therapy for sickle cell disease, including 16 in the last quarter. Casgevy, which has been slow to launch, earned $30.4 million from second-quarter sales.
Business Wire
04-08-2025
- Business
- Business Wire
Vertex Announces Results from Phase 2 Study of VX-993 for the Treatment of Acute Pain
BOSTON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced topline results from its recently completed Phase 2, randomized, double-blind, placebo-controlled dose-ranging study evaluating the safety and efficacy of its investigational selective NaV1.8 pain signal inhibitor, VX-993, in treating acute pain after bunionectomy surgery. Treatment with VX-993 did not result in a statistically significant improvement on the primary endpoint of the time-weighted Sum of the Pain Intensity Difference from 0 to 48 hours (SPID48) compared to placebo. VX-993 was generally safe and well tolerated. Most adverse events (AEs) were mild to moderate, and there were no serious adverse events (SAEs) related to VX-993. Based on these results, Vertex will not progress VX-993 into pivotal development as monotherapy in acute pain. 'This proof-of-concept study was powered to test whether VX-993 would result in higher clinical efficacy than previously demonstrated with the NaV1.8 pathway,' said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex. 'Based on these results, as well as the totality of preclinical data and results from our previous bunionectomy clinical studies, VX-993 is not expected to be superior to our existing NaV1.8 inhibitors and therefore we will not be advancing it as monotherapy in acute pain.' Primary Efficacy Outcomes Chart 367 patients were enrolled in the study All p-values are based on individual comparisons to placebo CI: confidence interval Safety Results VX-993 was generally safe and well tolerated at all doses studied in the trial. The overall incidence of adverse events on VX-993 was similar to placebo. The majority of the AEs were mild or moderate in severity. There were no SAEs related to VX-993 in the study. No patients treated with VX-993 discontinued study drug due to AEs. The most common AEs (incidence >5% in either combined VX-993, hydrocodone bitartrate/acetaminophen (HB/APAP) or placebo group, respectively) were nausea (4.1%, 14.7%, 11.3%), headache (2.7%, 6.7%, 1.4%), dizziness (1.4%, 5.3%, 1.4%) and vomiting (1.4%, 5.3%, 2.8%). Adverse events were generally consistent with the post-surgical setting. About the VX-993 Phase 2 Acute Pain Study The Phase 2 study was a randomized, double-blind, placebo-controlled, dose-ranging study that evaluated three different doses of VX-993 administered orally in 367 patients with acute pain following bunionectomy surgery. The study also included a hydrocodone bitartrate/acetaminophen (HB/APAP) reference arm. The primary endpoint was the time-weighted Sum of the Pain Intensity Difference (SPID) over the first 48 hours of treatment, as recorded on the 11-point Numeric Pain Rating Scale (NPRS), compared to placebo. The study was designed to test whether greater NaV1.8 inhibition with VX-993 would translate to higher efficacy than what has already been demonstrated with other NaV1.8 inhibitors. The study was powered accordingly to demonstrate a treatment effect higher than previously achieved. Patients were randomized to 5 treatment arms: VX-993 high dose — 180 mg first dose and 90 mg every 12 hours (at 12, 24 and 36 hours after the first dose), VX-993 mid dose — 70 mg first dose and 35 mg every 12 hours (at 12, 24 and 36 hours after the first dose), or VX-993 low dose — 10 mg first dose and 5 mg every 12 hours (at 12, 24 and 36 hours after the first dose), the reference arm of HB/APAP 5 mg/325 mg administered orally every 6 hours over 42 hours, or placebo. Patients reported their pain intensity on the NPRS at each scheduled time point through 48 hours. The first dose of study drug was administered on the day of surgery, approximately 3 hours post-operatively on average. In order to maximize pain severity, a popliteal block was not used in this study. VX-993 is investigational and has not been approved by health authorities globally. About Vertex Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 15 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit or follow us on LinkedIn, Facebook, Instagram, YouTube and X. Special Note Regarding Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements by Carmen Bozic, M.D., in this press release, and statements regarding Vertex's expectations for VX-993 as a treatment for acute pain, and the company's plans not to progress VX-993 as a monotherapy in acute pain. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from the company's clinical programs may not support registration or further development of its compounds due to safety, efficacy or other reasons, and other risks listed under the heading 'Risk Factors' in Vertex's most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission at and available through the company's website at You should not place undue reliance on these statements, or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available. (VRTX-GEN)
